Micro Medical Solutions' MicroStent With 120-cm Delivery Catheter Receives CE Mark Approval

November 5, 2018—Micro Medical Solutions (MMS) announced that it has received European CE Mark approval for its 4-F–compatible MicroStent 120-cm delivery catheter, as well as MicroStent devices in five lengths and five diameters to meet individual patient needs. The MicroStent vascular stent is specifically designed to reduce below-the-knee amputations caused by critical limb ischemia (CLI) resulting from peripheral artery disease.

According to the company, the new 120-cm MicroStent catheter allows for treatment via multiple access points above the knee, thereby expanding and optimizing the treatment options for CLI. In addition, the newly approved MicroStent sizes of 8,15, 25, 40, and 60 mm will allow physicians to choose the stent length based on the best fit for each patient’s diseased artery, allowing for a more customized approach.

Robert E. Beasley, MD, commented in MMS's announcement, “For patients with CLI, insufficient blood flow to the lower leg causes pain and, eventually, tissue damage. The end result can be amputation below the knee. When we implant the MicroStent, we restore the vessel, alleviate pain, and ultimately save the limb. The 120-cm catheter gives us more options, so we can choose the best access point for each patient. The new, robust 3.2-F shaft provides excellent push and control when transmitting movement from the more distant femoral access point. It’s the perfect balance of femoral access and control.” Dr. Beasley is with Mount Sinai Medical Center in Miami Beach, Florida.

The company noted that the MicroStent device achieved CE Mark approval in 2017. The first case using the device in the United States was performed in 2018. A phase 1 FDA clinical trial is concluding, with results expected as early as December 2018, advised Micro Medical Solutions.